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The purpose of this study is to evaluate the clinical efficacy of alpha-blocker monotherapy and alpha-blocker + 5-alpha reductase inhibitor combination therapy in benign prostate hyperplasia patients, and suggest guidelines of the combination therapy.

Condition or disease

Intervention/treatment

Phase

Benign Prostate Hyperplasia

Drug: TamsulosinDrug: FinasterideDrug: Placebo

Phase 4

Detailed Description:

Even though it should be decided on patients cautiously under careful consideration about prostate volume, Prostate Specific Antigen(PSA) level, symptom score and maximum uroflow, recently the combination therapy of alpha-blocker and 5-alpha reductase inhibitor has been tried imprudently in Korea.

As a result of several clinical trials which had conducted overseas for releasing the combination drug of alpha-blocker and 5-alpha reductase inhibitor, the superiority of the combination therapy has been proved, however, plenty of patients still don't derive additional profit from it.

Therefore, in this study, the investigators anticipate to meet with meaningful results on the clinical efficacy of alpha-blocker monotherapy and alpha-blocker + 5-alpha reductase inhibitor combination therapy in Korean benign prostate hyperplasia patients, and provide guidelines of the combination therapy.

Clinical Progression [ Time Frame: 1 & 2 months after baseline, and then every 3 months up to 4 years ]

One of below

Deterioration of the symptoms

Acute urinary retention

Renal failure

Recurrent urinary tract infection

Urinary incontinence

Surgical procedure related to benign prostate hyperplasia

Secondary Outcome Measures
:

International Prostate Symptom Score(IPSS) [ Time Frame: 1 & 2 months after baseline, and then every 3 months up to 4 years ]

International Consultation on Incontinence Modular Questionnaire(ICIQ) male LUTS-short form [ Time Frame: every 6 months up to 4 years ]

Uroflowmetry [ Time Frame: every 6 months up to 4 years ]

including Qmax, voided volume and post-void residual volume(PVR)

Prostate volume [ Time Frame: every 1 year up to 4 years ]

Global Response Assessment(GRA) [ Time Frame: every 1 year up to 4 years ]

PSA level [ Time Frame: every 1 year up to 4 years ]

PSA level will be examined in the central laboratory and be reported to each center as an adjusted number. It is because PSA level tends to decrease to 50% of baseline after taking finasteride for 1~4 years, so there is possibilities that the blindedness is broken with the actual result.

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Ages Eligible for Study:

50 Years and older (Adult, Senior)

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Male patients aged over 50

Clinically diagnosed benign prostate hyperplasia(BPH)

8 ≤ IPSS ≤ 30

4 ml/sec ≤ Q max ≤ 15 ml/sec

minimum voided volume ≥ 125 ml

Post voided residual volume ≤ 250

Volunteer who singed on informed consent documents

Exclusion Criteria:

Past history of surgical procedure experience related to BPH

Past history of taking 5-alpha reductase inhibitor(5-ARI) within 6 months before screening, or for more than 12 months regardless of the point of time

Past history of taking alpha blocker within 2 weeks before screening

Past history of acute urinary retention within 3 months before screening

Serum PSA ≥ 10 ng/ml (but, in the case of 4 ng/ml ≤ PSA < 10 ng/ml, the patients can be included only if prostate cancer is excluded by prostate biopsy)